IRB Applications and Forms

The applications and forms shown below are updated on a regular basis. Please download a new copy each time you use them to ensure you are using the most current version. Also note that many of the forms/application have both a Behavioral/Social Sciences version and a Health Sciences version. Please make sure that you are using the correct type. Forms are available for download in MS Word (PC) and Rich Text Format (MAC) by clicking the "W" or "Apple" icons.

The SMOG Readability Tool is a recommended and tested method for determining the readability level of written materials.

Behavioral/Social Science Forms and Applications

  Behavioral/Social Sciences Application (Form #1124)
  Instructions - Behavioral/Social Sciences Application
  Behavioral/Social Sciences Expedited Application (Form #1119)
  Instructions - Behavioral/Social Sciences Expedited Application
  Behavioral/Social Sciences Continuing Review Application (Form #1129)
  Instructions - Behavioral/Social Sciences Continuing Review Application
  Exemption Request (Form #1102)
  Instructions - Exemption Request Form
  Specimen/Data Repository Application (Form #1103)
  Instructions - Specimen/Data Repository Application
  Specimen/Data Continuing Review Application (Form #1137)
  Umbrella Request (Form #1106)
  Instructions - Umbrella Request
  Umbrella Continuing Review Application (Form #1113)
  Instructions - Umbrella Continuing Review Application

Health Science Forms and Applications

NEW
11/4/2009
Health Sciences Application (Form #1100)
NEW
11/4/2009
Instructions - Health Sciences Application
  Health Sciences Expedited Application (Form #1133)
  Instructions - Health Sciences Expedited Application
  Health Sciences Continuing Review Application (Form #1101)
  Instructions - Health Sciences Continuing Review Application
  Coordinating Center Application (Form #1125)
  Exemption Request (Form #1102)
  Instructions - Exemption Request Form
  Specimen/Data Repository Application (Form #1103)
  Instructions - Specimen/Data Repository Application
  Specimen/Data Continuing Review Application (Form #1137)
  Umbrella Request (Form #1106)
  Instructions - Umbrella Request
  Umbrella Continuing Review Application (Form #1113)
  Instructions - Umbrella Continuing Review Application

HSRC/RDRC Applications

  FDA Form 2915
  Human Subjects Radiation (HSRC) Application (Form #1107)
  Instructions - Human Subjects Radiation (HSRC) Application
  Radioactive Drug Research (RDRC) Application (Form #1108)
  Instructions - Radioactive Drug Research (RDRC) Application
  Radiation Dose Calculator    

Supplemental Forms

  Coded Data Agreement (Form #1142)
  Coordinating Center Supplemental Form (Form #1132)
Department Chair/Division Chief Signature Form
  Financial Liability Supplemental Form (Form #1140)
NEW
11/4/2009
Phase I and Phase I/II Supplemental Form (Form #1143)
NEW
11/4/2009
Instructions - Phase I and Phase I/II Supplemental Form
  Specimen/Data Repository Supplemental Form (Form #1136)
  Supplemental Form for Devices (Form #1134)
  Instructions - Supplemental Form for Devices
  Supplemental Form for Drugs/Biologics (Form #1135)
  Vulnerable Population Form - Children (Form #1117)
  Instructions - Vulnerable Population (Children)
  Vulnerable Population Form - Cognitively Impaired (Form #1118)
  Instructions - Vulnerable Population Form (Cognitively Impaired)
  Vulnerable Population Form - Pregnant Women/Fetus/Neonate/Fetal Material (Form #1116)
  Instructions - Vulnerable Population Form (Pregnant Women/Fetus/Neonate/Fetal Material)
  Vulnerable Population Form - Prisoners (Form #1115)
  Instructions - Vulnerable Population Form (Prisoners)

Informed Consent and Assent Documents

  Assent Document
  Behavioral/Social Sciences - Standard Informed Consent Document
  Health Sciences - Standard Informed Consent Document
  Informed Consent Document - Short Form
  Informed Consent Document - Emergency Use
  Instructions - Informed Consent, Assent, and Short Form
  Informed Consent Document - Spanish Short Form
  Instructions - Spanish Short Form
  Surrogate Rider for Informed Consent Document
  Translator Declaration Statement
  Waiver of Consent and/or Authorization to Access PHI (Form #1112)
  Instructions - Waiver of Consent and/or Authorization to Access PHI

Additional Forms

  Adverse Event Report (Form #1105)
  Instructions - Adverse Event Report
  Adverse Event Reporting Flowchart
  Complaint Report (Form #1114)
  Confidentiality Agreement
  Conflict of Interest Opinion Request (Form #1120)
  Conflict of Interest Decision Tree
  Data Use Agreement (Form #1109)
  FDA Form 1571 - Investigational New Drug Application (IND)
  FDA Form 1572 - Statement of Investigator
  FDA Form 2891 - Investigational New Device (IDE) (submit in triplicate)  
  Non-Human/Non-Research Determination Request (Form #1122)
  Instructions - Non-Human/Non-Research Determination
  Protocol Deviation Report (Form #1123)
  Instructions - Protocol Deviation Report
  MOU Site Checklist



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Contact the IRB | Last modified: November 04, 2009